MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-06-22 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[47926884]
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Patient Sequence No: 1, Text Type: N, H10
[47926925]
The customer stated that their phosphate (inorganic) ver. 2 - phos controls were high on (b)(6) 2016 on the c501 analyzer. The customer then recalibrated the assay and controls were within range after this. On the morning of (b)(6) 2016, controls were low. The customer then replaced the reagent cassette and repeated controls. The controls recovered within range. The customer tried running controls on the old cassette, but these were still low. The customer then calibrated the old cassette and repeated controls. The controls recovered within range. The customer later stated that phos results were questioned for a total of 10 patient samples. Of the 10 samples, four had initial erroneous results that were reported outside of the laboratory. The customer stated that the samples were initially repeated on a different c501 analyzer, but they then repeated the samples on the original c501 analyzer using the new reagent pack. The customer was asked, but could not specify which analyzer was used for each provided repeat result. The customer states that the samples were repeated on both c501 analyzers and repeat results were identical for each. The repeat results were believed to be correct and corrected reports were issued. The first sample initially resulted as 1. 3 mg/dl. The sample was repeated, resulting as 2. 3 mg/dl. The second sample, from a (b)(6) female, initially resulted as 2. 1 mg/dl. The sample was repeated, resulting as 3. 1 mg/dl. The third sample, from a (b)(6) male, initially resulted as 2. 9 mg/dl. The sample was repeated, resulting as 3. 9 mg/dl. The fourth sample, from a (b)(6) male, initially resulted as 1. 5 mg/dl. The sample was repeated, resulting as 2. 6 mg/dl. It was asked, but it is not known if the patients were adversely affected. No adverse events were alleged. The phos reagent lot number was 61756001, with an expiration date of 11/30/2016. The field service representative determined that there was a fluidics failure of the rinse mechanism. He stated that the line going to the rinse mechanism was clogged, causing restriction of the correct dispensation of rinse levels. He cleaned and flushed the line with bleach and deionized water. He adjusted the rinse levels to specification. He ran precision studies and results were within specification. The customer successfully ran quality controls. An issue with either the reagent or pre-analytic sample handling can be excluded based on investigation findings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-00797 |
| MDR Report Key | 5741508 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-22 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-06-07 |
| Date Mfgr Received | 2016-06-08 |
| Date Added to Maude | 2016-06-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CEO |
| Date Received | 2016-06-22 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-22 |